Clearance Summary
Uterine Aspiration Set received FDA 510(k) clearance under submission number K251882, sponsored by Gcmedica Enterprise Ltd.(Wuxi). The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2025-10-16.
- Submission: K251882
- Applicant / Sponsor: Gcmedica Enterprise Ltd.(Wuxi)
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1175
- Decision date: 2025-10-16
Classification & Regulation
This clearance is catalogued under FDA product code HHK and 21 CFR 884.1175, within the Obstetrics/Gynecology review panel as a Class II device.